Last synced on 27 January 2023 at 11:04 pm

Post Breast Biopsy Hemostatic Breast Compression Device

Page Type
Product Code
Definition
To achieve and maintain hemostasis of a breast biopsy wound site.
Physical State
The device is typically a solid material (e.g., plastic block with characteristic geometry) that can adequately interface and compress tissue at or around a bleeding biopsy wound.
Technical Method
The devices are designed to be used in conjunction with stereotactic biopsy platforms.
Target Area
The device generally targets skin soft tissue.
Regulation Medical Specialty
Radiology
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
892.1710
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 892.1710 Mammographic x-ray system

§ 892.1710 Mammographic x-ray system.

(a) Identification. A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

(b) Classification. Class II.

Post Breast Biopsy Hemostatic Breast Compression Device

Page Type
Product Code
Definition
To achieve and maintain hemostasis of a breast biopsy wound site.
Physical State
The device is typically a solid material (e.g., plastic block with characteristic geometry) that can adequately interface and compress tissue at or around a bleeding biopsy wound.
Technical Method
The devices are designed to be used in conjunction with stereotactic biopsy platforms.
Target Area
The device generally targets skin soft tissue.
Regulation Medical Specialty
Radiology
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
892.1710
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 892.1710 Mammographic x-ray system

§ 892.1710 Mammographic x-ray system.

(a) Identification. A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

(b) Classification. Class II.